JPH04235942A - Granulation of powdery calcium acetate - Google Patents

Granulation of powdery calcium acetate

Info

Publication number
JPH04235942A
JPH04235942A JP7025091A JP7025091A JPH04235942A JP H04235942 A JPH04235942 A JP H04235942A JP 7025091 A JP7025091 A JP 7025091A JP 7025091 A JP7025091 A JP 7025091A JP H04235942 A JPH04235942 A JP H04235942A
Authority
JP
Japan
Prior art keywords
calcium acetate
sieve
granulation
nominal size
granulated
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
JP7025091A
Other languages
Japanese (ja)
Inventor
Hiroshi Nakai
中井 洋
Tadao Fujie
藤江 忠雄
Akiko Kaneko
金子 明子
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
Original Assignee
Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Priority to JP7025091A priority Critical patent/JPH04235942A/en
Publication of JPH04235942A publication Critical patent/JPH04235942A/en
Pending legal-status Critical Current

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  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)

Abstract

PURPOSE:To granulate powdery calcium acetate for obtaining granules optimal as a phosphoric acid adsorbent for patients with chronic renal failure. CONSTITUTION:The objective granulation is characterized by comprising the following five processes: (1) grinding process for powdery calcium acetate, (2) kneading process where 100 pts.wt. of the calcium acetate ground is incorporated with 40 pts.wt. of water and the mixture is kneaded, (3) granulation process where the calcium acetate kneaded is extruded using a sieve with meshes of a specified nominal size, (4) drying process where the calcium acetate granulated is put to air-drying at room temperature, and (5) dividing process where the resulting agglomerated granules are divided using a second sieve with meshes of a nominal size smaller than that for the former sieve used in the process 3. With the present method, the fluidity of the finally granulated calcium acetate will be increased, leading to highly facilitating its packaging in portions and simplifying its tableting through encapsulation, and also getting easy to take it for patients with chronic renal failure.

Description

【発明の詳細な説明】[Detailed description of the invention]

【0001】0001

【産業上の利用分野】本発明は、粉末酢酸カルシウムの
顆粒化法に関し、さらに詳しくは慢性腎不全患者に対す
るリン酸の吸着剤として最適な粉末酢酸カルシウムの顆
粒化法に関する。
BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a method for granulating powdered calcium acetate, and more particularly to a method for granulating powdered calcium acetate, which is most suitable as an adsorbent for phosphoric acid for patients with chronic renal failure.

【0002】0002

【従来の技術】従来、粉末酢酸カルシウムを顆粒化する
方法は存在しなかった。これは、そもそも粉末酢酸カル
シウム等のカルシウム塩は水和状態にて加圧により一旦
硬化が起こると元には戻らないという性質があり、その
ため顆粒化が困難であった。
BACKGROUND OF THE INVENTION Hitherto, there has been no method for granulating powdered calcium acetate. This is because calcium salts such as powdered calcium acetate have a property that once they harden under pressure in a hydrated state, they do not return to their original state, which makes it difficult to granulate them.

【0003】0003

【発明が解決しようとする課題】近年人工腎臓治療を受
けている慢性腎不全患者は我が国において約10万名に
達している。このように多数存在する慢性腎不全患者は
、自らの力では腎臓からリン酸を***することができず
、また人工腎臓によるリン酸の***も不十分であったた
め、体内中のリン酸値が高まる高リン酸血症に罹患する
ことが多かった。従来この高リン酸血症の対策として、
食物中のリン酸を小腸から吸収するのを防止する目的で
水酸化アルミニウムゲルをリン酸の吸着剤として服用す
るが、この場合は水酸化アルミニウムゲル中のアルミニ
ウムは体内に蓄積してアルミニウム脳症(痴呆)やアル
ミニウム骨症(骨軟化症)を惹起していた。
[Problems to be Solved by the Invention] In recent years, the number of chronic renal failure patients receiving artificial kidney treatment has reached approximately 100,000 in Japan. These many patients with chronic renal failure are unable to excrete phosphoric acid from their kidneys on their own, and the excretion of phosphoric acid by the artificial kidneys is also insufficient, resulting in low levels of phosphoric acid in the body. They often suffered from increased hyperphosphatemia. Conventionally, as a countermeasure for this hyperphosphatemia,
Aluminum hydroxide gel is taken as a phosphate adsorbent to prevent dietary phosphoric acid from being absorbed from the small intestine, but in this case, the aluminum in the aluminum hydroxide gel accumulates in the body, causing aluminum encephalopathy (aluminum encephalopathy). This caused dementia) and aluminum osteopathy (osteomalacia).

【0004】このため本発明者等は、水酸化アルミニウ
ムの代わりに酢酸カルシウムをリン酸吸着剤として使用
することに着目した。酢酸カルシウムを使用する場合に
おいては、水酸化アルミニウムにおける前述のような問
題点は起こらない。一般に酢酸カルシウム等のカルシウ
ム塩は、粒子径が小さく、水和状態にて凝集性の強い粉
体であるため、処方箋実施の際の分包誤差が著しく、調
剤に非常に苦労しているのが現実である。我が国におい
て酢酸カルシウムは化学品として粉末状のもののみが製
造されており、錠剤やカプセル剤としての薬剤を製造し
たり、正確な分包をするというようなことは出来ず、か
つこれをそのまま服用するにしても粉末状であるため服
用しにくい等の問題点があった。本発明は、上記の問題
点を解消した粉末酢酸カルシウムの顆粒化法を提供しよ
うとするものである。
For this reason, the present inventors focused on using calcium acetate as a phosphoric acid adsorbent instead of aluminum hydroxide. When calcium acetate is used, the aforementioned problems with aluminum hydroxide do not occur. In general, calcium salts such as calcium acetate have small particle diameters and are highly cohesive powders in a hydrated state, which causes significant packaging errors when filling prescriptions, making dispensing very difficult. It's reality. In Japan, calcium acetate is only manufactured in powder form as a chemical product, and it is not possible to manufacture drugs in the form of tablets or capsules or to package them accurately, and it is difficult to take them as they are. Even if it were, there were problems such as it being difficult to take because it was in powder form. The present invention aims to provide a method for granulating powdered calcium acetate that solves the above problems.

【0005】[0005]

【課題を解決するための手段】このため本発明では粉末
酢酸カルシウムの粉砕工程と、粉末酢酸カルシウムを1
00重量部に対し水40重量部を添加して練り合わせる
練合工程と、この練り合わされた酢酸カルシウムを所定
呼び寸法の篩を用いて押し出す造粒工程と、造粒された
酢酸カルシウムを室温で風乾する乾燥工程と、造粒工程
で用いた篩よりも目の細かい呼び寸法の篩で凝集粒子を
細分する細分工程とからなる粉末酢酸カルシウムの顆粒
化法をもって、課題解決のための手段とするものである
[Means for Solving the Problems] Therefore, in the present invention, the powdered calcium acetate is pulverized and the powdered calcium acetate is
A kneading process in which 40 parts by weight of water is added to 00 parts by weight, a granulation process in which the kneaded calcium acetate is extruded using a sieve with a predetermined nominal size, and the granulated calcium acetate is mixed at room temperature. A method for granulating powdered calcium acetate, which consists of a drying process in which it is air-dried, and a subdivision process in which aggregated particles are subdivided using a sieve with a nominal size smaller than that used in the granulation process, is a means to solve the problem. It is something.

【0006】[0006]

【実施例】以下、本発明の実施例を説明する。粉末を顆
粒化する方法としては、乾式顆粒化法と、湿式顆粒化法
の二種があり、何れも主薬を分級し賦形剤(乳糖、白糖
、ソルビット、澱粉等)・崩壊剤(澱粉、結晶セルロー
ス、カルボキシメチルセルロースカルシウム等)・結合
剤(ゼラチン、アラビアゴム、グルコース、カルボキシ
メチルセルロースナトリウム等)を加えて混合するのが
通常である。本発明は湿式顆粒化法に属し、水以外の添
加物を一切必要とせず、カルシウム塩の特性上造粒され
た顆粒は元の粉末には戻らない特徴がある。もちろん、
必要に応じて賦形剤・崩壊剤・矯味剤を加えて服用条件
を改善することは可能である。
[Examples] Examples of the present invention will be described below. There are two methods for granulating powder: dry granulation and wet granulation, both of which classify the active ingredient and add excipients (lactose, sucrose, sorbitol, starch, etc.) and disintegrants (starch, Usually, a binder (gelatin, gum arabic, glucose, sodium carboxymethylcellulose, etc.) is added and mixed. The present invention belongs to the wet granulation method and does not require any additives other than water, and due to the characteristics of the calcium salt, the granulated granules do not return to the original powder. of course,
It is possible to improve the dosing conditions by adding excipients, disintegrants, and flavoring agents as necessary.

【0007】実施例1 1.酢酸カルシウム(Ca(CH3COO)2・H2O
)を乳鉢中で可能な限り細かく粉砕し、必要に応じて8
0〜100号(呼び寸法177〜150μm)篩を通す
(粉砕工程)。 2.酢酸カルシウムをボールに入れ、撹拌しながら均一
に万遍なく水を噴霧する。水の量は、室内湿度50〜7
5%の条件下で酢酸カルシウム1000gに対し、40
0gとした。この状態で全体が顆粒状になるまで3〜5
分間練合した(練合工程)。 3.練合した酢酸カルシウムを16号(呼び寸法119
0μm)篩を用いて、自然落下状態で押し出し造粒した
(造粒工程)。 4.造粒した酢酸カルシウムを模造紙上に薄く拡げ、4
5〜50℃で風乾した(乾燥工程)。 5.顆粒を約8分通り乾燥したとき、20号(呼び寸法
1000μm)篩を通して凝集粒子を細分し、顆粒を十
分乾燥した後、80号(呼び寸法177μm)篩で粉末
部分を除き、粉末は次のロット仕込み時に再利用する(
細分工程)。実施例1の結果は下記の表1に示す通りで
あった。
Example 1 1. Calcium acetate (Ca(CH3COO)2・H2O
) in a mortar as finely as possible, and if necessary
Pass through a No. 0 to 100 (nominal size 177 to 150 μm) sieve (pulverization step). 2. Place calcium acetate in a bowl and spray water evenly and evenly while stirring. The amount of water is indoor humidity 50-7
40% for 1000g of calcium acetate under 5% condition.
It was set to 0g. 3 to 5 minutes in this state until the whole becomes granular.
The mixture was kneaded for a minute (kneading step). 3. Mixed calcium acetate No. 16 (nominal size 119)
Using a sieve (0 μm), the mixture was extruded and granulated in a natural falling state (granulation step). 4. Spread the granulated calcium acetate thinly on the paper and
It was air-dried at 5-50°C (drying step). 5. When the granules were dried for about 8 minutes, the agglomerated particles were finely divided through a No. 20 sieve (nominal size 1000 μm), and after the granules were thoroughly dried, the powder portion was removed using a No. 80 sieve (nominal size 177 μm). Reuse when preparing lots (
subdivision process). The results of Example 1 were as shown in Table 1 below.

【0008】[0008]

【表1】[Table 1]

【0009】製品(A)が求める顆粒である場合、製品
(B)やロス分は、その後の連続製造時に他のロット分
に混入させることができる。実施例で示したように、少
量生産では主薬と水と顆粒化のための篩と主薬の練合の
ための乳鉢と、顆粒乾燥のための容器のみで十分であり
、造粒のポイントは添加すべき水の量的範囲と、練合の
時間的範囲並びにその均質さである。なお実施例では、
粉体の流動性の目安である安息角(粉体を堆積させると
きの粉体層の自由表面と水平面のなす角)が60゜から
37°に変化し、嵩密度が0.31g/mlから0.5
2g/mlへと約1.7倍に増大して、充填性が向上し
非常に扱い易い顆粒になった。ここで安息角は、通常4
0〜30°が扱い易く、50°以上では流動性が大変低
下する。また加えられた水は風乾の過程でほとんど散失
し、原粉末とほぼ同じ含水率(約10%)であることを
熱分析器で確認した。
[0009] When the product (A) is the desired granule, the product (B) and the loss can be mixed into other lots during subsequent continuous production. As shown in the examples, for small-scale production, only the main ingredient, water, a sieve for granulating, a mortar for kneading the main ingredient, and a container for drying the granules are sufficient, and the key to granulation is the addition These are the quantitative range of water to be mixed, the temporal range of kneading, and its homogeneity. In addition, in the example,
The angle of repose (the angle between the free surface of the powder layer and the horizontal plane when depositing the powder), which is a measure of the fluidity of powder, changes from 60° to 37°, and the bulk density changes from 0.31 g/ml to 37°. 0.5
The granules were increased approximately 1.7 times to 2 g/ml, resulting in improved filling properties and very easy to handle granules. Here, the angle of repose is usually 4
0 to 30° is easy to handle, and if it is 50° or more, the fluidity decreases significantly. Furthermore, most of the added water was lost during the air-drying process, and it was confirmed using a thermal analyzer that the moisture content was almost the same as the original powder (approximately 10%).

【0010】0010

【発明の効果】よって本発明は、顆粒化された酢酸カル
シウムの流動性が高まり、分包が極めて容易となり、酢
酸カルシウムをカプセルに封入したり錠剤化したりする
ことも簡単になり、慢性腎不全患者にとって直接服用す
ることも容易になる等のすぐれた効果がある。
[Effects of the Invention] Therefore, the present invention improves the fluidity of granulated calcium acetate, makes it extremely easy to package, and makes it easy to encapsulate calcium acetate or make it into tablets. It has excellent effects such as making it easier for patients to take it directly.

Claims (1)

【特許請求の範囲】[Claims] 【請求項1】粉末酢酸カルシウムの粉砕工程と、粉末酢
酸カルシウムを100重量部に対し水40重量部を添加
して練り合わせる練合工程と、この練り合わされた酢酸
カルシウムを所定呼び寸法の篩を用いて押し出す造粒工
程と、造粒された酢酸カルシウムを室温で風乾する乾燥
工程と、造粒工程で用いた篩よりも目の細かい呼び寸法
の篩で凝集粒子を細分する細分工程とからなる粉末酢酸
カルシウムの顆粒化法。
Claim 1: A step of crushing powdered calcium acetate, a kneading step of adding and kneading 40 parts by weight of water to 100 parts by weight of powdered calcium acetate, and passing the kneaded calcium acetate through a sieve of a predetermined nominal size. A drying process in which the granulated calcium acetate is air-dried at room temperature, and a subdivision process in which the aggregated particles are subdivided using a sieve with a nominal size finer than the sieve used in the granulation process. Granulation method of powdered calcium acetate.
JP7025091A 1991-01-16 1991-01-16 Granulation of powdery calcium acetate Pending JPH04235942A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP7025091A JPH04235942A (en) 1991-01-16 1991-01-16 Granulation of powdery calcium acetate

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
JP7025091A JPH04235942A (en) 1991-01-16 1991-01-16 Granulation of powdery calcium acetate

Publications (1)

Publication Number Publication Date
JPH04235942A true JPH04235942A (en) 1992-08-25

Family

ID=13426129

Family Applications (1)

Application Number Title Priority Date Filing Date
JP7025091A Pending JPH04235942A (en) 1991-01-16 1991-01-16 Granulation of powdery calcium acetate

Country Status (1)

Country Link
JP (1) JPH04235942A (en)

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH11130673A (en) * 1997-10-31 1999-05-18 Eisai Co Ltd Extrusion-granulated composition
US7997703B2 (en) 2003-03-26 2011-08-16 Seiko Epson Corporation Liquid container
US8563032B2 (en) * 2005-12-05 2013-10-22 Roxane Laboratories, Inc. Formulation and manufacturing process for calcium acetate capsules
US8808735B2 (en) 2005-02-03 2014-08-19 Takeda Nycomed As Fast wet-massing method for the preparation of calcium-containing compositions
JP2014200215A (en) * 2013-04-08 2014-10-27 大東化学株式会社 Food additive, calcium acetate powder, and manufacturing method thereof

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH11130673A (en) * 1997-10-31 1999-05-18 Eisai Co Ltd Extrusion-granulated composition
US7997703B2 (en) 2003-03-26 2011-08-16 Seiko Epson Corporation Liquid container
US8808735B2 (en) 2005-02-03 2014-08-19 Takeda Nycomed As Fast wet-massing method for the preparation of calcium-containing compositions
US8563032B2 (en) * 2005-12-05 2013-10-22 Roxane Laboratories, Inc. Formulation and manufacturing process for calcium acetate capsules
US9060951B2 (en) 2005-12-05 2015-06-23 Roxane Laboratories, Inc. Formulation and manufacturing process for calcium acetate capsules
US10300020B2 (en) 2005-12-05 2019-05-28 West-Ward Pharmaceuticals International Limited Formulation and manufacturing process for calcium acetate capsules
JP2014200215A (en) * 2013-04-08 2014-10-27 大東化学株式会社 Food additive, calcium acetate powder, and manufacturing method thereof

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